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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter B - Food for Human Consumption |
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Part 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food |
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Subpart F - Requirements Applying to Records That Must Be Established and Maintained |
§ 117.335 - Special requirements applicable to a written assurance.
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§ 117.335 Special requirements applicable to a written assurance.
(a) Any written assurance required by this part must contain the following elements:
(1) Effective date;
(2) Printed names and signatures of authorized officials;
(3) The applicable assurance under:
(ii) Section 117.136(a)(3);
(iii) Section 117.136(a)(4);
(iv) Section 117.430(c)(2);
(v) Section 117.430(d)(2); or
(vi) Section 117.430(e)(2);
(b) A written assurance required under § 117.136(a)(2), (3), or (4) must include:
(1) Acknowledgement that the facility that provides the written assurance assumes legal responsibility to act consistently with the assurance and document its actions taken to satisfy the written assurance; and
(2) Provision that if the assurance is terminated in writing by either entity, responsibility for compliance with the applicable provisions of this part reverts to the manufacturer/processor as of the date of termination.